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Active, Not Recruiting

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata - IM011-134

Aktualisiert: 27 März, 2024   |   ClinicalTrials.gov

Zusammenfassung zum Ausdrucken

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Studiendetails

  • Phase 2

    Phase

  • Geschlecht(er)

  • 18-65

    Altersgruppe

  • Active, Not Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: Deucravacitinib Dose 1
Drug: Deucravacitinib Other: Placebo
Experimental: Deucravacitinib Dose 2
Drug: Deucravacitinib Other: Placebo
Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.

Wichtigste Eignungskriterien

Inclusion Criteria: - Documented clinical diagnosis of Alopecia Areata (AA) for at least 6 months. - Current episode of scalp hair loss (at screening) must meet the following criteria: duration at least 6 months; duration of current hair loss episode of AA affecting ≥ 50% of the scalp not exceeding 8 years; scalp hair loss has been stable (no significant spontaneous regrowth [> 10%] over the last 6 months) - SALT score ≥ 50 at Screening and Day 1. Participant with complete scalp hair loss (SALT score of 100) with or without body hair involvement can be included. Exclusion Criteria: - Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc. - Other active skin diseases affecting the scalp that in the opinion of the investigator may interfere with accurate assessment of SALT score. - Extensive tattooing of the scalp that, in the opinion of the investigator, may interfere with the accurate assessment of SALT score. Other protocol-defined inclusion/exclusion criteria apply.

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